Phase 2
N=85
Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin
Chemotherapy-Induced Nausea and Vomiting · Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01012336 ↗Enrolled (actual)
85
Serious AEs
2.3%
Results posted
Oct 2012
Primary outcome: Primary: Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy. — 89.4 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aprepitant/Ramosetron/Dexamethasone (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Samsung Medical Center
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy. |
89.4 | — |
| PRIMARY Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen |
— | — |
| SECONDARY Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy |
— | — |
| SECONDARY Time to First Vomiting Episode or Use of Rescue Medication |
— | — |
Summary
The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.
Eligibility Criteria
Inclusion criteria
- patient is over 18 years
- ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy
- Karnofsky score > 60
- Life expectancy > 4 months
Exclusion criteria
- Any of following conditions (mentally incapacitated or emotional or psychiatric disorder, user of any illicit drugs, has an active infection, hypersensitivity to ramosetron or aprepitant)
- Patients have received a nonapproved drug within last 4 weeks
- abnormal laboratory values (AST > 2.5 normal, ALT > 2.5 normal, Bilirubin > 1.5 normal, Creatinine > 1.5 normal)
- Antiemetic drugs within 48 hours of study
- Benzodiazepine or opiate within 48 hours
- CYP3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
- CYP3A4 inhibitors (clarithromycin, ketoconazole)
- CYP3A4 inducers within 30 days (Barbiturates, rifampicin, carbamazepine)
Data sourced from ClinicalTrials.gov (NCT01012336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.